MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, LEFT, SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR FEMORAL CEM, LEFT, SZ 4
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 years post initial left side tka, the male patient presented for a revision knee due to femoral loosening.Femur debonded from cement during extraction.Patient received full revision of femur component.Patient was last known to be in stable condition following the event.Images received.The device is not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision due to aseptic femoral loosening reported most likely was the result of mechanical loss of fixation.Contributions from cement technique, excessive resection of the femoral bone and/or patient conditions to the failure cannot be determined from the provided information and the devices were not available for evaluation.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d8, d10, e4 (remove erroneous entry from initial report), h6 clinical code, component code, types of investigation findings and investigation conclusions.D10: lgc tibial fit tray cem sz 4f / 4t, (category#: 02-012-45-4040, serial#: (b)(6), logic cr tib insert std, sz 4, 11mm, (category#: 02-012-47-4011, serial#: (b)(6), three peg patella 38mm, (category#: 200-02-38, serial#: (b)(6).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR FEMORAL CEM, LEFT, SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15902490
• Report Number: 1038671-2022-01551
• Device Sequence Number: 5016345
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2026
• Device Model Number: LOGIC CR FEMORAL CEM, LEFT, SZ 4
• Device Catalogue Number: 02-010-03-0240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 04/14/2023; 04/16/2026
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 05/01/2023; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T.; LOGIC CR TIB INSERT STD, SZ 4, 11MM.; SEE H11.; THREE PEG PATELLA 38MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male